Kornimate/medical-research-clean huggingface dataset:
thrust manipulation vs. non-thrust mobilizations for mechanical neck pain

Conditions: Neck Pain

Summary: the purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. both of these techniques have been compared in previous trials but a pragmatic approach will be employed as well as controlling for clinical equipoise.

a total sample size of 136 subjects with mechanical neck pain will be recruited to participant in this trial from multiple clinic and university sites around the country. each subject will be evaluated by a licensed physical therapist that specializes in orthopedic manual therapy (omt). each treating therapist will be blinded be the data collection and each data collection therapist will be blinded to the treatment allocation. subjects data will be collected at the initial visit, second visit, and at discharge. the maximum number of weeks that a subject may be enrolled is 8 weeks (2 months). at that point, they are discharged from the study. the treating therapist will allocate the subject through the already completed randomization procedures. once the subject is randomized, the treating therapist will perform the omt based on their clinical reasoning and in a manner they feel would benefit the patient the most. in addition to the omt, each subject will receive a home exercise program, advice, encouragement, and education. a number of outcome variables will be collected regarded pain and disability as well as one physical performance measure.

Eligibility criteria:
inclusion criteria: * chief complaint of neck pain. (non-specific neck pain with a primary location between the superior nuchal line and the first thoracic spinous process) * age \>18 * a minimum neck disability index (ndi) score ≥ 20% exclusion criteria: * contraindications to omt including; malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use. * nerve root compression diagnosed as having at least 2 of the following: * upper extremity muscle weakness within a specific cervical/thoracic myotome * diminished deep tendon reflexes of the biceps brachii, brachioradialis, or triceps muscle. * diminished sensation to light touch or pinprick in a specific upper extremity dermatome. * history of neck or thoracic spine surgery * neck pain of \<2 on the nprs * currently receiving other forms of conservative care and unwilling to stop for the duration of their participation in the study. * any pending litigation related to their neck pain * therapist is unable to elicit the chief complaint with passive accessory intervertebral movements (paivm).
the effect of mindfulness-based practices and deep relaxation exercises in pregnant women

Conditions: Anxiety; Pregnancy Related

Summary: pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. however, mindfulness-based approaches affect pregnancy outcomes positively. data collected with the "personal description form", and "the pregnancy-related anxiety questionnaire-revised 2".

pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. however, mindfulness-based approaches affect pregnancy outcomes positively. the aim of this study, which was conducted to determine the effects of mindfulness practices and deep relaxation exercises on the level of pregnancy-related anxiety, is to create intervention programs compatible with the prenatal period and to contribute to the improvement of pregnancy outcomes. first of all, a total of 111 pregnant women (37 mindfulness based stress reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in the study. however, we recalculated the power analysis with a reference study after obtaining approval and before starting the study. with the calculation we made with the reference study, we determined our final sample number as 102 pregnant women (34 individuals for the mindfulness meditation group, 34 individuals for the deep relaxation exercises group, and 34 individuals for the control group). data collected with the "personal description form", and "the pregnancy-related anxiety questionnaire-revised 2". mindfulness and deep relaxation practices was applied by midwives who are experts in their fields who are certified in these fields.

Eligibility criteria:
inclusion criteria: * having internet access, * without any diagnosed psychiatric health problem, * at 12-24 weeks of gestation, * there is no risk factor in pregnancy, * literate, * using smart phone, * having a headset accessory for phone calls, * pregnant women who voluntarily agreed to participate in the study exclusion criteria: -mental disabilities
efficacy of non contrast dwi(diffusion weighted imaging) imaging compared to dmr-de

Conditions: Heart Attack

Summary: use of mri and dwi to diagnose cardiac scarring after heart attack.

to discover new information about mri (magnetic resonance imaging) called dwi (diffusion weighted imaging) and its ability to diagnose cardiac scarring. cmr-de (cardiac mr with delayed contrast enhancement) evaluates if there has been scarring in the heart muscle following a heart attack. subjects are injected with a contrast medication that makes the scarring visible if present. to prove the efficacy of dwi (diffusion weighted imaging) to provide the same images that cmr-de (cardiac magnetic resonance with delayed contrast enhancement) provides.

Eligibility criteria:
inclusion criteria: * males and females 21 years of age and older * healthy volunteers * subjects with a prior history of heart attack and prior cmr-de imaging. exclusion criteria: * women who are pregnant * subjects with gfr \< 60 ml/min/1.73m2 * subjects with icd * subjects with coronary stents incompatible with 3t
evaluation of safety and performance of the cytacoat lubricious infection prevention (lip) foley catheter

Conditions: Safety of the CytaCoat LIP Foley Catheter; Tolerability of the CytaCoat LIP Foley Catheter

Summary: the goal of this pilot safety and tolerability study is to determine whether the novel cytacoat lip (lubricious infection prevention) foley catheter is safe to use in patients during short term use. the primary objective of this study is to determine the safety and tolerability for the medical device cytacoat lip foley catheter in patients undergoing transurethral resection of the bladder (tur-b) surgery. safety will be assessed by evaluation of adverse events. the secondary objective is to assess the overall performance by evaluating if there were any foley catheter handling problems experienced by the healthcare personnel with the use of the cytacoat lip foley catheter. exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire. participants will be catheterized with either a cytacoat foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. after removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the numerical rating scale (nrs) (0-10). a similar assessment will be performed 7-10 days after removal of the catheter. in addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the nrs scale (0-10), using a questionnaire. urine samples will be taken before and after catheterization and evaluated through quantification.


Eligibility criteria:
inclusion criteria: * will be undergoing a tur-b procedure. * able to give informed consent by signing and dating the written informed consent document acknowledging their desire to participate in the study. * adults, age 18 to 84 years. * require insertion of a size 12, 14, 16, 18 or 20 french foley catheter after tur-b surgery. * be able to understand and comply with the information given in the patient consent form. exclusion criteria: * vulnerable subjects such as children, pregnant or breastfeeding women, or potentially immune-compromised subjects. * unable to provide informed consent. * has a known bacteriuria or a current urinary tract infection. * has a known bloodstream infection or an infection that requires prolonged antibiotic therapy. * has an ongoing antibiotic therapy. * cannot accommodate a size 12, 14, 16, 18 or 20 fr foley catheter or requires a thiemann tip foley catheter. * previous enrolment in the present study. * simultaneous participation in another clinical study that may impact the primary endpoint. * severe non-compliance to protocol as judged by the pi.
effects of dynamic stabilizatıon exercises and hvla manipulatıon in low back paın

Conditions: Low Back Pain; Neuromuscular Subluxation of Joint

Summary: our aim is to contribute to the literature by comparatively examining the effects of dns exercises and chiropractic hvla manipulation on pain, pain-related functional impairment (disability), physical competence level, dynamic fitness level of core muscles and postural deviations in patients with chronic nonspecific low back pain.

sixty volunteers aged between 20 and 45 years will participate in this study. before starting the study, anthropological measurements (height, weight, body mass index) were made. after these measurements, the participants will be randomly divided into four groups. the groups will be formed as chiropractic manipulation (cm) group (n=15), dynamic neuromuscular stabilization (dns) group (n=15), cm + dns group (n=15) and control group (cg) (n=15). the km group will receive 8 sessions of high velocity low amplitude (hvla) chiropractic manipulation twice a week for 4 weeks and the dns group will receive 8 sessions of (dns) exercise twice a week for 4 weeks and each session will last 50 minutes. the km+dns group will receive a total of 8 sessions of dns exercises and hvla chiropractic manipulation twice a week for 4 weeks. participants will be assessed a total of 3 times during the study; just before the intervention starts, 2 weeks after the intervention starts, after the 4th session, 4 weeks after completing the intervention, after the 8th session. participants will be assessed with visual analog scale (vas), roland morris disability questionnaire (rmdq), dynamic neuromuscular stabilization - heel slip test (dns-hs), oswety disability index (odi) and posture assessment will be performed using posturescreen mobile application.

Eligibility criteria:
inclusion criteria: * 7 points in oswetry disability index (odi) * participants should be between the ages of 20 and 45 * normal radicular tests * being diagnosed with low back pain 6 months * not having perception problems and being able to cooperate well * signing the voluntary consent form exclusion criteria: * pregnancy * history of previous spinal canal surgery * presence of neurological deficits * presence of cancer * having an inflammatory or rheumatologic disease * spinal deformities (due to infection or trauma, compression fracture)

Keywords: spinal manipulation dynamic neuromuscular stabilization low back pain posture non - spesific
safety and local tolerability of prevenar in indian children

Conditions: Pneumococcal Infections

Summary: this postmarketing surveillance study will evaluate the safety profile of prevenar in indian children. prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by streptococcus pneumoniae serotypes 4, 6b, 9v, 14, 18c, 19f and 23f. prevenar has been marketed in india since june 2006. the board of health in india has given restricted permission to import and market prevenar. the present study is a post-approval regulatory commitment to the board of health in india. this is an observational study and the protocol for the study has been approved by the board of health.


Eligibility criteria:
inclusion criteria subjects must meet at least one of the following conditions to be eligible for inclusion in the study: for primary immunization schedule: * healthy male or female subjects 6 weeks + 5 days of age with no previous prevenar vaccination * for catch-up immunization schedule: * healthy male or female subjects 12-23 months of age exclusion criteria subjects with any of the following conditions or characteristics will be excluded from the study. * a known or suspected history of streptococcus pneumoniae disease. * a previous anaphylactic or other severe vaccine-associated adverse event. * a known or suspected impairment of immune system (including hiv infection), or recipient of immunosuppressive agents. * a major congenital, developmental or serious chronic disorder. * a confirmed or suspected underlying evolving neurological disorder or history of seizures. * a history of thrombocytopenia or any coagulation disorder. * any acute illness at the time of vaccine administration

Keywords: pneumococcal infections/pc (prevention & control)
breast health in chinese american women

Conditions: Breast Cancer

Summary: this four-and-a-half-year study will test the efficacy of viewing a theoretically based and culturally sensitive video followed by group discussion (vs. single viewing) in increasing mammography use. the results of this study will lead cancer control efforts to effectively decrease breast cancer screening disparities experienced by chinese-america women.

we will conduct a 4.5-year community-based rct to study the impact of intervention approaches (small-group video discussion vs. single video mode) on mammography used among chinese immigrant women. the small-group video discussion will be led by trained chinese community health educators and trained bilingual research staff using a standardized structured protocol at all sites. in the single video mode, we will mail the intervention materials to women to view and/or read at home. we will recruit 974 chinese women through our strong and well-established chinese community partnerships in the metropolitan areas of washington, dc (lead pi: dr. judy wang, georgetown university-gu), new york (site pi: dr. grace ma at temple university), and southern california (site pi: dr. annette maxwell, university of california, los angeles-ucla). participants' eligibility are listed under "eligibility criteria". we will not enroll us-born chinese women as they are least likely to face cultural and language barriers to mammography and less likely to engage in our small-group discussion, which will be conducted in chinese languages. also, we will not enroll short-term visitors as our study involves four interviews over a 2-year period.

Eligibility criteria:
inclusion criteria: 1. first generation chinese women 2. aged 42 and older 3. have not had a mammogram in the past 2 years 4. have never had breast cancer 5. lived in the metropolitan dc, southern ca, and ny suburb; and 6. have no mammography screening scheduled in the next 6 month from time of enrollment exclusion criteria: 1. short-term visitors 2. us-born chinese americans

Keywords: chinese women mammography breast cancer
assessment of relative bioavailability of nktr-118 in three formulations in healthy subjects

Conditions: Healthy

Summary: the is an assessment of relative bioavailability of nktr-118 in three formulations in healthy subjects.


Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study-specific procedures * females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: * post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (fsh) levels in the laboratory defined post-menopausal range * irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation * volunteers must have a body mass index (bmi) between 18 and 30 kg/m2 and weigh at least 50 kg * volunteers must be able to understand and be willing to comply with study procedures, restrictions and requirements * healthy male and non-fertile female volunteers ages 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture exclusion criteria: * any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the absorption, distribution, metabolism, and excretion of drugs * current smokers, those who have smoked or used nicotine products within the previous 3 months from the date of screening (visit 1) * plasma donation within 1 month of screening or any blood donation/blood loss \>500 ml during the 3 months prior to screening or intention to donate blood or blood products during the study or within 3 months after the completion of the study * positive screen for drugs of abuse, or cotinine (nicotine level above 400 ng/ml), at screening or admission and/or positive alcohol test at admission * any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Keywords: phase 1 pharmacokinetics nktr-118 fasting or fed state cross-over study auc(0-t) cmax tmax qtcf interval
generation of organoids of neuroendocrine neoplasms of the gastro-entero-pancreatic tract obtained from patients undergoing surgery

Conditions: Gastro-entero-pancreatic Neoplasms

Summary: observational, prospective, feasibility pilot study of the preparation of organoids starting from tumor tissue and surrounding healthy tissue, collected during surgery, performed according to standard clinical practice.

given the need for the use of experimental models that mimic the tumor of origin

Eligibility criteria:
inclusion criteria: * over 18 years of age; * diagnosis of gep-nen carried out via histological investigation or via positivity to the uptake pet-ct with 68ga-peptides; * availability of adequate material for the preparation of organoid cultures, derived from surgery; * written informed consent. exclusion criteria: * previous chemotherapy treatments
exercise: improving compliance and long-term weight loss

Conditions: Obesity

Summary: the overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the sanford profile program. participants are randomized to one of three groups: in-class yoga, yoga by digital video disk (dvd), stretching by dvd. changes in weight loss and stress levels are monitored.

the overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the sanford profile program. the 6-month study includes a 3-month randomized, controlled trial using in-person yoga, a yoga dvd, and a stretching dvd (control group) followed by a 3-month post-intervention follow-up. the study will be conducted to test the hypotheses that both in-person yoga classes and dvd yoga participation will result in 1) greater compliance with the profile program, 2) greater weight loss during the yoga intervention, and 3) greater weight loss 3 months following completion of the intervention compared to the stretching intervention. compliance will be investigated using percent of days that dietary intake was entered online and percent of days that online records indicate that the program was followed. changes in weight will be measured using data transmitted from electronic scales that are provided as part of the profile program. in order to assess weight change after participation in the intervention we will ask participants to continue weighing themselves daily for 3 months following completion of the intervention regardless of whether they completed the profile program or not. participants will complete online questionnaires on behavioral and appetite perceptions related to eating, food intake, stress levels, compliance with diet recommendations given to them by sanford profile, and perceived benefits of their intervention. we will use these measures to determine the effect of yoga participation on eating behaviors and stress levels.

Eligibility criteria:
inclusion criteria: * must be participants in the sanford profile program (weight loss program) exclusion criteria: * must have physician approval if answers yes to physical activity readiness questionnaire (parq) questions
gore® excluder® thoracoabdominal branch endoprosthesis in the treatment of type iv thoracoabdominal aortic aneurysms

Conditions: Thoracoabdominal Aortic Aneurysm

Summary: this study will assess the initial feasibility of the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device) in the treatment of aortic aneurysms involving the visceral branch vessels.

this is a prospective, non-randomized study designed to assess the feasibility of the tambe device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. a maximum of 10 subjects will be treated under this protocol. this clinical study will include up to six sites in the us. each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (ct) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the gore® excluder® thoracoabdominal branch endoprosthesis implant.

Eligibility criteria:
inclusion criteria: 1. aortic aneurysm involving the visceral vessels requiring treatment 2. adequate access for tambe device components 3. appropriate aortic anatomy to receive the tambe device 4. age ≥ 18 years at the time of informed consent signature 5. male or infertile female 6. the patient is considered high risk for open repair as deemed by the treating physician 7. capable of complying with protocol requirements, including follow-up 8. an informed consent form signed by subject or legal representative note: additional inclusion criteria may apply exclusion criteria: 1. prior aortic surgery 2. ruptured or leaking aortic aneurysm 3. aneurysmal dilatation due to chronic aortic dissection 4. infected aorta 5. mycotic aneurysm 6. life expectancy \<2 years 7. myocardial infarction or stroke within 6 weeks of treatment 8. systemic infection which may increase risk of endovascular graft infection 9. degenerative connective tissue disease, e.g. marfan's or ehler-danlos syndrome 10. participation in another drug or medical device study within 1 year of study enrollment 11. history of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment 12. tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access 13. known sensitivities or allergies to the device materials 14. previous instance of heparin induced thrombocytopenia type 2 (hit-2) or known hypersensitivity to heparin 15. patient has body habitus or other medical condition which prevents adequate fluoroscopic and ct visualization of the aorta 16. renal insufficiency note: additional exclusion criteria may apply